Pulmonary Hypertension Due to Left Heart DiseasePhase 2RECAPTURENCT04882774

Telemonitoring to Treat Group 2 Pulmonary Hypertension

A Phase 2 study testing Treprostinil Diolamine in people with Pulmonary Hypertension Due to Left Heart Disease, run by Mardi Gomberg -Maitland MD, MSc at 3 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Pulmonary Hypertension Due to Left Heart Disease
What is being tested?: Treprostinil Diolamine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 3 sitesUnited States
Study dates: Apr 2023to Apr 2027
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

The subject voluntarily gives informed consent to participate in the study.
The subject is 18 to 85 years of age (inclusive) at Baseline (i.e., date of providing written informed consent).
The subject has a diagnosis of heart failure with a LVEF ≥45% by ECHO completed prior to randomization.
The subject has a CardioMEMS device implanted as standard of care for a minimum of 30 days at Baseline.
The subject has pulmonary function tests conducted within 12 months of Baseline or to confirm the following:
Total lung capacity is ≥ 60% of the predicted value.

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Forced expiratory volume at 1 second (FEV1) is ≥50% of the predicted value.
Diffusing capacity of the lungs for carbon monoxide (DLCO) is ≥ 32% of the predicted value (unadjusted or adjusted for alveolar volume).
Subjects should be on maximally tolerated HFpEF therapies (e.g., ACE inhibitors, ARBs, beta blockers, SLG2 inhibitors) for ≥30 days prior to enrollment unless contraindicated. The exception is with changes of anticoagulants and/or diuretics; these medications should not be newly started or stopped within 14 days of enrollment and no healthcare provider prescribed dose change should occur within 7 days of enrollment, with the exception of the withholding of doses of anticoagulants for the conduct of the RHC when required.
In the opinion of the Investigator, the subject is able to communicate effectively with study personnel, and is considered reliable, willing, and likely to be cooperative with protocol requirements, including attending all study visits.
Subjects on chronic medications (e.g. inhaled corticosteroids, long-acting beta2-adrenergic agonist, long-acting muscarinic antagonists, combination inhaled drugs, anti-inflammatory drugs, oral/parenteral corticosteroids, or biologic agents) for any underlying respiratory condition must be on a stable dose for ≥30 days prior to randomization.

Who cannot join

The subject is pregnant or lactating.
In the opinion of the Principal Investigator, the subject has a primary diagnosis of PH other than WHO Group 2 PH.
The subject has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation of therapy or inability to effectively titrate that therapy.
The subject has received PAH therapies, including prostacyclin therapy (i.e., epoprostenol, treprostinil, iloprost, or beraprost; except for acute vasoreactivity testing), nonprostanoid IP receptor agonist (selexipag), ERA, or soluble guanylate cyclase stimulator, within 30 days of enrollment. If the Investigator does not intend to keep a subject on their PDE5-I therapy, it must be stopped at least 30 days prior to enrollment. Intermittent use of a PDE5-I (≤3 times per week) to treat erectile dysfunction is permitted.
The subject has been hospitalized for a cardiopulmonary indication within 30 days of randomization.
The subject had a myocardial infarction within 90 days of enrollment.

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The subject had cardiac resynchronization therapy within 90 days of enrollment or anticipated resynchronization therapy during the study treatment period.
The subject has liver function tests (aspartate aminotransferase [AST] or alanine aminotransferase [ALT]) greater than 3 times the upper limit of normal at Screening, clinically significant liver disease/dysfunction per Investigator's clinical judgement, known Child-Pugh Class C hepatic disease or noncirrhotic portal hypertension.
The subject has uncontrolled systemic hypertension, defined as a systolic blood pressure >160 mmHg or a diastolic blood pressure >110 mmHg at Baseline on more than one occasion during screening.
The subject has a systolic blood pressure <100 mmHg at Baseline.
The subject has a resting heart rate >110 beats per minute at Baseline.
The subject has sarcoidosis or cardiac amyloidosis.
The subject has a known history of any LVEF less than 40% by ECHO within 3 years of enrollment. Note: a transient decline in LVEF below 40% that occurred and recovered more than 6 months before the start of Screening and was associated with an acute intercurrent condition (e.g., atrial fibrillation) is allowed.
The subject has hemodynamically significant valvular heart disease as determined by the Investigator, including:
Greater than mild aortic and/or mitral stenosis
Severe mitral and/or aortic regurgitation (>Grade 3)
The subject has a body mass index >45 kg/m2.
The subject has any musculoskeletal disorder (e.g., arthritis affecting the lower limbs, recent hip or knee joint replacement, artificial leg), or has any other condition that would likely be the primary limit to ambulation as opposed to the disease under study.
The subject has end-stage renal disease requiring/receiving dialysis.
The subject has used any investigational drug/device, or participated in any investigational study, within 30 days prior to the Baseline visit.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Ohio State University
Columbus, Ohio, 43210
Allegheny Singer Research Institute
Pittsburgh, Pennsylvania, 15212
George Washington University
Washington D.C., District of Columbia, 20037

Other trials in United States

About this study

Official title: Telemonitoring to Treat Group 2 Pulmonary Hypertension: A Personalized Approach

This study aims to decrease elevated pressure in the lungs of patients with pulmonary hypertension from left heart with elevated pulmonary vascular resistance by utilizing aggressive fluid management with ReDS Pro System and CardioMEMS device. Participants with persistently elevated pulmonary pressure at Week 16 will begin oral treprostinil in combination with the fluid management plan while those with improved pressures maintain their fluid management plan for an additional 16 weeks.

Read the detailed description

This study hypothesizes that monitoring with ReDS-Pro System (ReDS), aggressive fluid management, and the CardioMEMS device (a 3-prong approach) will improve CpcPH (combined pre and post capillary pulmonary hypertension) hemodynamics (Total Pulmonary Resistance [TPR] and mPAP). For patients who continue to have an elevate pulmonary vascular resistance (TPR) at Week 16, with ReDS, aggressive fluid management, and the CardioMEMS device should allow successful titration of oral treprostinil by preventing titration related pulmonary edema and by improving hemodynamics, activity monitoring and six minute walk test (6MWT) after 16 weeks of therapy.

Conditions: Pulmonary Hypertension Due to Left Heart Disease
Being tested: Treprostinil Diolamine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treprostinil DiolamineDrug
Oral treprostinil 0.125 mg TID titrated as clinically indicated and tolerated to a maximum of 6 mg TID

Study groups in NCT04882774
Study group	Role	What they receive
Fluid Management	No intervention	Fluid management protocol only
Oral Treprostinil	Experimental	Drug - oral treprostinil Receives: Drug: Treprostinil Diolamine

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of participants with normal lung impedance as measured by the ReDS vest in Ohms at Week 16
Number of participants reaching normal lung impedance (< 34 Ω) based on ReDS vest management.
Measured: 16 weeks
Number of participants with normal total pulmonary resistance as measured by CardioMEMS in Woods Units at Week 16
Number of participants reaching normal total pulmonary resistance (< 5 Woods Units) as measured by CardioMEMS.
Measured: 16 weeks
Number of participants reaching normal lung impedance with oral treprostinil at Week 32
Number of participants reaching normal lung impedance (<34 Ω) from Week 16 to Week 32 with oral treprostinil administration.
Measured: 16 weeks
Number of participants reaching normal total pulmonary resistance with oral treprostinil at Week 32
Number of participants reaching normal total pulmonary resistance (goal < 5 U) from Week 16 to Week 32 with oral treprostinil administration.
Measured: 16 weeks
Number of participants decreasing six-minute walk distance with oral treprostinil at Week 32
Number of participants with a six-minute walk distance decrease of >15% from Week 16 to Week 32 with oral treprostinil administration.
Measured: 16 weeks
Number of participants maintaining normal lung impedance as measured by the ReDS vest at Week 32
Number of participants maintaining normal lung impedance (< 34 Ω) from Week 16 to Week 32 as measured by ReDS vest.
Measured: 16 weeks
Number of participants maintaining total pulmonary resistance as measured by CardioMEMS at Week 32
Number of participants maintaining normal TPR (< 5 U) from Week 16 to Week 32 as measured by CardioMEMS.
Measured: 16 weeks

Secondary outcomes (17)

WHO Functional Class
Change in Functional Class (FC) Week 16, 32.
Measured: 32 weeks
Change in cardiac output
Change in cardiac output (L/min) as measured by CardioMEMS from Baseline to Week 16, 32.
Measured: 32 weeks
Change in cardiac index
Change in cardiac index (L/min/m2) as measured by CardioMEMS from Baseline to Week 16, 32.
Measured: 32 weeks
Change in right ventricular stroke volume
Change in right ventricular stroke volume (mL) as measured by CardioMEMS from Baseline to Week 16, 32.
Measured: 32 weeks
Change in stroke volume index
Change in stroke volume index (mL/m2) as measured by CardioMEMS from Baseline to Week 16, 32.
Measured: 32 weeks
Change in elastance
Change in elastance (mmHg/mL) as measured by CardioMEMS from Baseline to Week 16, 32.
Measured: 32 weeks
Change in compliance
Change in compliance (mL/mmHg) as measured by CardioMEMS from Baseline to Week 16, 32.
Measured: 32 weeks
Change in right ventricular power
Change in right ventricular power (W) as measured by CardioMEMS from Baseline to Week 16, 32.
Measured: 32 weeks
Change in cardiac efficiency
Change in cardiac efficiency (mL/mmHg) as measured by CardioMEMS from Baseline to Week 16, 32.
Measured: 32 weeks
Change in right ventricular stroke work
Change in right ventricular stroke work (mmHg/mL) as measured by CardioMEMS from Baseline to Week 16, 32.
Measured: 32 weeks
Change in stroke work index
Change in stroke work index (g x m/m2) as measured by CardioMEMS from Baseline to Week 16, 32.
Measured: 32 weeks
Change in NT-proBNP
Change in N-terminal pro-brain natriuretic peptide (NT-proBNP) levels from Baseline to Week 16, 32.
Measured: 32 weeks
Kansas City Cardiomyopathy Questionnaire
Improvement in Kansas City Cardiomyopathy Questionnaire (KCCQ) at Baseline to Week 16 and baseline to Week 32. Scores are scaled from 0 to 100 and summarized in quartiles representing health status with higher scores indicating better status: 0 to 24=very poor to poor; 25 to 49=poor to fair; 50 to 74=fair to good; and 75 to 100= good to excellent.
Measured: 32 weeks
Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire
Improvement in PAH-SYMPACT at Baseline to Week 16, Baseline to Week 32. Measured using the Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire with higher scores indicating greater symptom severity or worse impact: scale of 0=no, 1=mild, 2=moderate, 3=severe, and 4=very severe.
Measured: 32 weeks
Number of participants with heart failure exacerbation
Adjudicated hospitalization or emergency department visits due to a heart failure decompensation.
Measured: 32 weeks
Six-minute walk test
Decrease in 6MWT >15% from Baseline (or too ill to walk) directly related to disease under study at 2 consecutive visits on different days.
Measured: 32 weeks
Number of participants who experienced mortality
Heart failure related deaths and all-cause mortality.
Measured: 32 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2023Apr 2027

First posted12 May 2021
Study startApr 2023 (estimated)
Primary completionApr 2025 (estimated)
Study completionApr 2027 (estimated)

Why it stopped: never opened to enrollment because it was never funded

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pulmonary Hypertension Due to Left Heart DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Model description: 32 week study in 30 subjects. Those who meet certain hemodynamic criteria at Week 16 will begin study drug and continue diuresis protocol while the remaining participants continue with the diuresis protocol only.
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04882774
Sponsor's protocol ID: RECAP001
Acronym: RECAPTURE
Status last verified: Jun 2023
First submitted: 27 Apr 2021
Last updated: 6 Jun 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
A Randomized Placebo-procedure Controlled Trial of the Enhancor System (PULmonary Artery Denervation) to Evaluate Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease
Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction
Active, not recruitingPhase 3
A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure
Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction
RecruitingObservational study
Evaluation of the BMPR2-Activin Signaling Pathway in Group II Pulmonary Hypertension.
Pulmonary Hypertension Due to Left Heart Disease, Pulmonary Hypertension (PH)
RecruitingObservational study
Hemodynamic Assessment of underLying myocyTe Function in Right Heart Failure
Heart Failure With Reduced Ejection Fraction, Pulmonary Hypertension
RecruitingObservational study
Pulmonary Hypertension Biorepository and Registry
Pulmonary Hypertension, Pulmonary Arterial Hypertension

All Pulmonary Hypertension Due to Left Heart Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Telemonitoring to Treat Group 2 Pulmonary Hypertension: A Personalized Approach
ClinicalTrials.gov ID: NCT04882774
Acronym / sponsor ID: RECAPTURE / RECAP001
Conditions: Pulmonary Hypertension Due to Left Heart Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: WithdrawnReason stopped: never opened to enrollment because it was never funded
Enrolment: 0 participants (actual)
Lead sponsor: Mardi Gomberg -Maitland MD, MScUniversity, hospital or other
Collaborators: Ohio State University, Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Study start: Apr 2023 (estimated)
Primary completion: Apr 2025 (estimated)
Study completion: Apr 2027 (estimated)
First posted: 12 May 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2
Model description: 32 week study in 30 subjects. Those who meet certain hemodynamic criteria at Week 16 will begin study drug and continue diuresis protocol while the remaining participants continue with the diuresis protocol only.

Arm	Type	Receives
Fluid Management	No intervention	–Fluid management protocol only
Oral Treprostinil	Experimental	Drug: Treprostinil DiolamineDrug - oral treprostinil

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

The subject voluntarily gives informed consent to participate in the study.
The subject is 18 to 85 years of age (inclusive) at Baseline (i.e., date of providing written informed consent).
The subject has a diagnosis of heart failure with a LVEF ≥45% by ECHO completed prior to randomization.
The subject has a CardioMEMS device implanted as standard of care for a minimum of 30 days at Baseline.
The subject has pulmonary function tests conducted within 12 months of Baseline or to confirm the following:

Key exclusion criteria (20 listed)

The subject is pregnant or lactating.
In the opinion of the Principal Investigator, the subject has a primary diagnosis of PH other than WHO Group 2 PH.
The subject has shown intolerance or significant lack of efficacy to a prostacyclin or prostacyclin analogue that resulted in discontinuation of therapy or inability to effectively titrate that therapy.
The subject has received PAH therapies, including prostacyclin therapy (i.e., epoprostenol, treprostinil, iloprost, or beraprost; except for acute vasoreactivity testing), nonprostanoid IP receptor agonist (selexipag), ERA, or soluble guanylate cyclase stimulator, within 30 days of enrollment. If the Investigator does not intend to keep a subject on their PDE5-I therapy, it must be stopped at least 30 days prior to enrollment. Intermittent use of a PDE5-I (≤3 times per week) to treat erectile dysfunction is permitted.
The subject has been hospitalized for a cardiopulmonary indication within 30 days of randomization.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Treprostinil DiolamineOral treprostinil 0.125 mg TID titrated as clinically indicated and tolerated to a maximum of 6 mg TID	Drug	Oral Treprostinil

Primary outcome

Number of participants with normal lung impedance as measured by the ReDS vest in Ohms at Week 16
Time frame: 16 weeks
Number of participants reaching normal lung impedance (< 34 Ω) based on ReDS vest management.
Number of participants with normal total pulmonary resistance as measured by CardioMEMS in Woods Units at Week 16
Time frame: 16 weeks
Number of participants reaching normal total pulmonary resistance (< 5 Woods Units) as measured by CardioMEMS.
Number of participants reaching normal lung impedance with oral treprostinil at Week 32
Time frame: 16 weeks
Number of participants reaching normal lung impedance (<34 Ω) from Week 16 to Week 32 with oral treprostinil administration.
Number of participants reaching normal total pulmonary resistance with oral treprostinil at Week 32
Time frame: 16 weeks
Number of participants reaching normal total pulmonary resistance (goal < 5 U) from Week 16 to Week 32 with oral treprostinil administration.
Number of participants decreasing six-minute walk distance with oral treprostinil at Week 32
Time frame: 16 weeks
Number of participants with a six-minute walk distance decrease of >15% from Week 16 to Week 32 with oral treprostinil administration.
Number of participants maintaining normal lung impedance as measured by the ReDS vest at Week 32
Time frame: 16 weeks
Number of participants maintaining normal lung impedance (< 34 Ω) from Week 16 to Week 32 as measured by ReDS vest.
Number of participants maintaining total pulmonary resistance as measured by CardioMEMS at Week 32
Time frame: 16 weeks
Number of participants maintaining normal TPR (< 5 U) from Week 16 to Week 32 as measured by CardioMEMS.

17 secondary outcomes

WHO Functional Class
Time frame: 32 weeks
Change in cardiac output
Time frame: 32 weeks
Change in cardiac index
Time frame: 32 weeks
Change in right ventricular stroke volume
Time frame: 32 weeks
Change in stroke volume index
Time frame: 32 weeks
Change in elastance
Time frame: 32 weeks
Change in compliance
Time frame: 32 weeks
Change in right ventricular power
Time frame: 32 weeks
Change in cardiac efficiency
Time frame: 32 weeks
Change in right ventricular stroke work
Time frame: 32 weeks
Change in stroke work index
Time frame: 32 weeks
Change in NT-proBNP
Time frame: 32 weeks
Kansas City Cardiomyopathy Questionnaire
Time frame: 32 weeks
Pulmonary Arterial Hypertension-Symptoms and Impact (PAH-SYMPACT) Questionnaire
Time frame: 32 weeks
Number of participants with heart failure exacerbation
Time frame: 32 weeks
Six-minute walk test
Time frame: 32 weeks
Number of participants who experienced mortality
Time frame: 32 weeks

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
Individual participant dataSharing planned: No

Related trials for Pulmonary Hypertension Due to Left Heart Disease

Recruiting
A Randomized Placebo-procedure Controlled Trial of the Enhancor System (PULmonary Artery Denervation) to Evaluate Safety and Efficacy in Patients With Combined Pre- and Post-capillary Pulmonary Hypertension Associated With Left Heart Disease
Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction
Active, not recruitingPhase 3
A Trial to Evaluate the Safety and Efficacy of Pulmonary Artery Denervation for the Treatment of Pulmonary Hypertension Associated With Left Heart Failure
Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction
RecruitingObservational study
Evaluation of the BMPR2-Activin Signaling Pathway in Group II Pulmonary Hypertension.
Pulmonary Hypertension Due to Left Heart Disease, Pulmonary Hypertension (PH)
RecruitingObservational study
Hemodynamic Assessment of underLying myocyTe Function in Right Heart Failure
Heart Failure With Reduced Ejection Fraction, Pulmonary Hypertension
RecruitingObservational study
Pulmonary Hypertension Biorepository and Registry
Pulmonary Hypertension, Pulmonary Arterial Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mardi Gomberg-Maitland, MD principal investigator

George Washington University

Raymond Benza, MD principal investigator

Ohio State University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Treprostinil Diolamine in people with Pulmonary Hypertension Due to Left Heart Disease, run by Mardi Gomberg -Maitland MD, MSc at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with normal lung impedance as measured by the ReDS vest in Ohms at Week 16 (time frame: 16 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04882774.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.